Betamethasone dip aug 0.05 cream.betamethasone dipropionate 0.05 % topical cream
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betamethasone dipropionate % topical cream | Kaiser Permanente. |
Betamethasone dip aug 0.05 cream. Betamethasone Dipropionate Cream, 0.05% (Augmented*)
Betamethasone Dipropionate Cream, % (Augmented*).
- Betamethasone dip aug 0.05 cream
Betamethasone, an analog of prednisolone, has high corticosteroid activity and slight mineralocorticoid activity. Betamethasone dipropionate is the 17,dipropionate ester of betamethasone. Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water. Each gram of betamethasone dipropionate ointment 0. The corticosteroids are a class of compounds comprising steroid hormones, secreted by the adrenal cortex and their synthetic analogs.
Topical corticosteroids, such as betamethasone dipropionate, are effective in the treatment of corticosteroid-responsive dermatoses primarily because of their anti-inflammatory, antipruritic, and vasoconstrictive actions.
However, while the physiologic, pharmacologic, and clinical effects of the corticosteroids are well known, the exact mechanisms of their actions in each disease are uncertain. Betamethasone dipropionate, a corticosteroid, has been shown to have topical dermatologic and systemic pharmacologic and metabolic effects characteristic of this class of drugs.
Topical corticosteroids can be absorbed from normal intact skin. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.
Eighty pediatric patients ages 6 months to 12 years, with atopic dermatitis, were enrolled in an open-label hypothalamic-pituitary-adrenal HPA axis safety study. Follow-up testing 2 weeks after study completion available for 2 of the 15 patients demonstrated a normally responsive HPA axis. Studies performed with betamethasone dipropionate ointment indicate that it is in the high range of potency as compared with other topical corticosteroids.
Betamethasone dipropionate ointment is a high-potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years and older. Betamethasone dipropionate ointment is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in these preparations.
Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area should be evaluated periodically for evidence of HPA axis suppression by using the urinary-free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.
Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. In an open-label pediatric study of 53 evaluable patients, of the 15 patients who showed evidence of suppression, 2 patients were tested 2 weeks after discontinuation of betamethasone dipropionate ointment, and both patients showed recovery of HPA axis function.
If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
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View more photos. Do not cover, bandage, or wrap the area unless directed to do so by your doctor. If you are using the lotion form of this medication, shake the bottle well before each dose.
Inform your doctor if your condition lasts or gets worse after 2 weeks. In the US - Call your doctor for medical advice about side effects. Before using this medication, tell your doctor or pharmacist your medical history, especially of: poor blood circulation immune system problems Do not use if there is an infection or sore present in the area to be treated.
Some products that may interact with this drug are: corticosteroids taken by mouth such as prednisone. Do not share this medication with others. Inform all your doctors you use or have used this medication. Information last revised September Copyright c First Databank, Inc. Drug Encyclopedia. No volver a mostrar esto.
No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. However, greater sensitivity of some older individuals cannot be ruled out. The only local adverse reaction reported to be possibly or probably related to treatment with betamethasone dipropionate cream, 0. It occurred in 1 patient, 0. Adverse reactions reported to be possibly or probably related to treatment with betamethasone dipropionate cream, 0.
The following local adverse reactions are reported infrequently when topical corticosteroids are used as recommended. These reactions dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria.
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. Apply a thin film of betamethasone dipropionate cream, 0. Treatment with betamethasone dipropionate cream, 0. Glenmark Generics Ltd. Additional barcode labeling by: Physicians Total Care, Inc. Tulsa, OK Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.
Information For Patients: Patients using topical corticosteroids should receive the following information and instructions. This medication is to be used as directed by the physician and should not be used longer than the prescribed time period.
It is for external use only. Avoid contact with the eyes. Patients should be advised not to use this medication for any disorder other than that for which it was prescribed. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive. Patients should report any signs of local adverse reactions. Other corticosteroid-containing products should not be used with betamethasone dipropionate cream, 0.
Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential of betamethasone dipropionate. Pregnancy: Teratogenic Effects: Pregnancy Category C: Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels.
Nursing Mothers: It is not known whether topical administration of corticosteroids can result in sufficient systemic absorption to produce detectable quantities in breast milk. Pediatric Use: Use of betamethasone dipropionate cream, 0. Geriatric Use: Clinical studies of betamethasone dipropionate cream, 0.
Manufactured: Glenmark Generics Ltd. Product Information.
Betamethasone dipropionate ointment contains betamethasone dipropionate, USP, a synthetic adrenocorticosteroid, for dermatologic use.
Betamethasone, an analog of prednisolone, has high corticosteroid activity and slight mineralocorticoid activity. Betamethasone dipropionate is the 17,dipropionate ester of betamethasone. Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water.
Each gram of betamethasone dipropionate ointment 0. The corticosteroids are a class of compounds comprising steroid hormones, secreted by the adrenal cortex and their synthetic analogs. Topical corticosteroids, such as betamethasone dipropionate, are effective in the treatment of corticosteroid-responsive dermatoses primarily because of their anti-inflammatory, antipruritic, and vasoconstrictive actions. However, while the physiologic, pharmacologic, and clinical effects of the corticosteroids are well known, the exact mechanisms of their actions in each disease are uncertain.
Betamethasone dipropionate, a corticosteroid, has been shown to have topical dermatologic and systemic pharmacologic and metabolic effects characteristic of this class of drugs. Topical corticosteroids can be absorbed from normal intact skin.
Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids.
Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.
Eighty pediatric patients ages 6 months to 12 years, with atopic dermatitis, were enrolled in an open-label hypothalamic-pituitary-adrenal HPA axis safety study. Follow-up testing 2 weeks after study completion available for 2 of the 15 patients demonstrated a normally responsive HPA axis. Studies performed with betamethasone dipropionate ointment indicate that it is in the high range of potency as compared with other topical corticosteroids.
Betamethasone dipropionate ointment is a high-potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years and older. Betamethasone dipropionate ointment is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in these preparations.
Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area should be evaluated periodically for evidence of HPA axis suppression by using the urinary-free cortisol and ACTH stimulation tests.
If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.
Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. In an open-label pediatric study of 53 evaluable patients, of the 15 patients who showed evidence of suppression, 2 patients were tested 2 weeks after discontinuation of betamethasone dipropionate ointment, and both patients showed recovery of HPA axis function.
Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted.
If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled. Information for Patients: This information is intended to aid in the safe and effective use of this medication.
It is not a disclosure of all possible adverse or intended effects. Patients using topical corticosteroids should receive the following information and instructions:. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. Patients should be advised not to use this medication for any disorder other than that for which it was prescribed.
Other corticosteroid-containing products should not be used with betamethasone dipropionate ointment without first talking to your physician. Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential of betamethasone dipropionate.
It was positive in the in-vitro human lymphocyte chromosome aberration assay, and equivocal in the in-vivo mouse bone marrow micronucleus assay. This pattern of response is similar to that of dexamethasone and hydrocortisone. Reproductive studies with betamethasone dipropionate carried out in rabbits at doses of 1.
These doses are approximately 0. Pregnancy: Teratogenic Effects: Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Betamethasone dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular route at doses of 0.
This dose is approximately 0. The abnormalities observed included umbilical hernias, cephalocele and cleft palates. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids.
Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time. Nursing Mothers : It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant.
Nevertheless, caution should be exercised when topical corticosteroids are prescribed for a nursing woman. Manifestations of adrenal suppression in pediatric patients include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen.
Chronic corticosteroid therapy may interfere with the growth and development of pediatric patients. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria.
Adverse reactions reported to be possibly or probably related to treatment with betamethasone dipropionate ointment during a pediatric clinical study include signs of skin atrophy telangiectasia, thinness, shininess, bruising, loss of skin markings. Apply a thin film of betamethasone dipropionate ointment 0. In some cases, a twice-daily dosage may be necessary. Betamethasone dipropionate ointment, USP 0. Patients using topical corticosteroids should receive the following information and instructions: 1.
Patients should report any signs of local adverse reactions. Laboratory Tests: The following tests may be helpful in evaluating HPA axis suppression: Urinary-free cortisol test ACTH stimulation test Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential of betamethasone dipropionate. Betamethasone dipropionate ointment is not to be used with occlusive dressings.
Distributed by: Actavis Pharma, Inc. Product Information. Inactive Ingredients. Marketing Information. Labeler - Actavis Pharma, Inc.
betamethasone dipropionate % topical cream This medication is used to treat a variety of skin conditions (such as eczema, dermatitis, allergies, rash). Betamethasone dipropionate cream, % (augmented) is a high-potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of. Betamethasone dipropionate cream, % (augmented) is a high-potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of. This medication is used to treat a variety of skin conditions (such as eczema, dermatitis, allergies, rash). Betamethasone reduces the swelling, itching. Betamethasone dipropionate ointment is a high-potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-. These doses are approximately 0. Rarely, it is possible this medication will be absorbed from the skin into the bloodstream.Betamethasone dipropionate cream, 0. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is the 17, dipropionate ester of betamethasone. Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water. Each gram of betamethasone dipropionate cream, 0. The corticosteroids are a class of compounds comprising steroid hormones secreted by the adrenal cortex and their synthetic analogs.
Topical corticosteroids, such as betamethasone dipropionate, are effective in the treatment of corticosteroid-responsive dermatoses primarily because of their anti-inflammatory, antipruritic, and vasoconstrictive actions. However, while the physiologic, pharmacologic, and clinical effects of the corticosteroids are well known, the exact mechanisms of their actions in each disease are uncertain.
Betamethasone dipropionate, a corticosteroid, has been shown to have topical dermatologic and systemic pharmacologic and metabolic effects characteristic of this class of drugs. The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.
Topical corticosteroids can be absorbed through normal intact skin. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Once absorbed through the skin, topical corticosteroids enter pharmacokinetic pathways similar to systemically administered corticosteroids.
Corticosteroids are bound to plasma proteins in varying degrees, are metabolized primarily in the liver and excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.
The results suggested that the drug caused a slight lowering of adrenal corticosteroid secretion, although in no case did plasma cortisol levels go below the lower limit of the normal range. Sixty-seven pediatric patients ages 1 to 12 years, with atopic dermatitis, were enrolled in an open-label, hypothalamic-pituitary-adrenal HPA axis safety study.
Studies performed with betamethasone dipropionate cream, 0. Systemic absorption of topical corticosteroids has produced reversible HPA axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.
Conditions which augment systemic absorption include the application of the more potent corticosteroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Use of more than one corticosteroid-containing product at the same time may increase total systemic glucocorticoid exposure. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests.
If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug.
In an open-label pediatric study of 60 evaluable patients, of the 19 who showed evidence of suppression 4 patients were tested 2 weeks after discontinuation of betamethasone dipropionate cream, 0. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity.
If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.
Patients using topical corticosteroids should receive the following information and instructions. This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects. Long-term animal studies have not been performed to evaluate the carcinogenic potential of betamethasone dipropionate. It was positive in the in-vitro human lymphocyte chromosome aberration assay, and equivocal in the in-vivo mouse bone marrow micronucleus assay.
This pattern of response is similar to that of dexamethasone and hydrocortisone. Reproductive studies with betamethasone dipropionate carried out in rabbits at doses of 1. Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Betamethasone dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular route at doses of 0.
This dose is approximately 0. The abnormalities observed included umbilical hernias, cephalocele and cleft palates. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.
There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time. It is not known whether topical administration of corticosteroids can result in sufficient systemic absorption to produce detectable quantities in breast milk.
Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Use of betamethasone dipropionate cream, 0. The proportion of patients with adrenal suppression in this study was progressively greater, the younger the age group. Hypothalamic-pituitary-adrenal HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation.
Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Chronic corticosteroid therapy may interfere with the growth and development of children. Clinical studies of betamethasone dipropionate cream, 0. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients.
However, greater sensitivity of some older individuals cannot be ruled out. The only local adverse reaction reported to be possibly or probably related to treatment with betamethasone dipropionate cream, 0.
It occurred in 1 patient, 0. Adverse reactions reported to be possibly or probably related to treatment with betamethasone dipropionate cream, 0. The following local adverse reactions are reported infrequently when topical corticosteroids are used as recommended.
These reactions dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria. Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects.
Apply a thin film of betamethasone dipropionate cream, 0. Treatment with betamethasone dipropionate cream, 0. Glenmark Generics Ltd. Additional barcode labeling by: Physicians Total Care, Inc.
Tulsa, OK Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Information For Patients: Patients using topical corticosteroids should receive the following information and instructions.
This medication is to be used as directed by the physician and should not be used longer than the prescribed time period. It is for external use only. Avoid contact with the eyes. Patients should be advised not to use this medication for any disorder other than that for which it was prescribed.
The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive. Patients should report any signs of local adverse reactions. Other corticosteroid-containing products should not be used with betamethasone dipropionate cream, 0. Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential of betamethasone dipropionate.
Pregnancy: Teratogenic Effects: Pregnancy Category C: Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Nursing Mothers: It is not known whether topical administration of corticosteroids can result in sufficient systemic absorption to produce detectable quantities in breast milk. Pediatric Use: Use of betamethasone dipropionate cream, 0. Geriatric Use: Clinical studies of betamethasone dipropionate cream, 0.
Manufactured: Glenmark Generics Ltd. Product Information. Inactive Ingredients. Marketing Information. Labeler - Physicians Total Care, Inc.
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